How you can help us grow End­points News through the pan­dem­ic

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Read­er en­gage­ment is the high­est we’ve ever seen as we ap­proach 80,000 dai­ly email sub­scribers — with over 20% of them un­der a paid plan. Busi­ness op­er­a­tions are strong, with our team of 17 de­ployed at home of­fices across the US, Eu­rope, and Asia be­fore it be­came manda­to­ry. And we can sell ad­ver­tis­ing to clients who need to reach a hy­per-fo­cused au­di­ence. It’s a way of reach­ing out, with­out touch­ing, that has be­come in­creas­ing­ly trendy. The vir­tu­al na­ture of our busi­ness gives us a few crit­i­cal ad­van­tages in re­spond­ing to the cri­sis.

There are chal­lenges, of course.

Live events ac­count for a third of our rev­enues — or used to, at least. Con­nect­ing the bio­phar­ma world is a vi­tal part of our mis­sion, and there’s no re­al sub­sti­tute for mak­ing new per­son­al con­nec­tions at con­fer­ences.

So un­til we’re able to meet in close quar­ters again — stretch­ing well in­to 2021 — all End­points events will be vir­tu­al. We’re start­ing with an ag­gres­sive slate of vir­tu­al Zoom pan­els fea­tur­ing the in­dus­try’s top lead­ers. We’ll have more on that soon. And the team is look­ing at new and in­no­v­a­tive ways at de­liv­er­ing these events, be­yond the stan­dard video pan­els. There’s a huge op­por­tu­ni­ty to reimag­ine on­line con­fer­ences and the val­ue they bring to both at­ten­dees and spon­sors.

To be sure, the bio­phar­ma in­dus­try it­self is demon­strat­ing some re­al re­silience in the cri­sis. That’s im­por­tant. Bio­phar­ma will be back, al­tered — cer­tain­ly — but more fo­cused on big things than ever be­fore.

We’re look­ing for­ward to writ­ing about that.

While we’ve been fo­cused on cov­er­ing the out­break and its im­pact on the in­dus­try — our spe­cial niche — we’ve put few­er sto­ries be­hind the pay­wall. That will change soon, and we need your sup­port now more than ever.

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For those of you who have a paid sub, thank you. For those of you get­ting one to­day, be sure that we have nev­er been more ap­pre­cia­tive of your sup­port for the in­de­pen­dent mis­sion we have carved out for our­selves as we boot­strapped this start­up.

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Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.